Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379938
Status:
TERMINATED
Last Update Posted:
2011-08-15
First Post:
2006-09-21
Brief Title:
B-19 Parvovirus Vaccine Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Study of the Safety and Immunogenicity of a Recombinant Human Parvovirus B-19 Vaccine
Status:
TERMINATED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigates the safety and effectiveness of a preventative vaccine for parvovirus B-19 infection Eighty-nine healthy adults ages 18-49 whose blood tests negative for B-19 will be enrolled Participants will be randomly chosen to receive 1 of 4 possible vaccine types low dose of the vaccine and an adjuvant substance which assists with transfer of medication to body high dose of the vaccine alone high dose of the vaccine and an adjuvant or saline substance containing no medication Participants will receive 3 vaccinations over a 6 month period and will be followed for 6 additional months Blood samples will be taken at months 1 2 6 7 and 12 to determine if antibody protein produced by the bodys immune system that recognizes and helps fight infections has been formed to the vaccine These tests measure vaccine efficacy ie determine if the vaccine induces immunity All participants will be followed closely for safety throughout the study
Detailed Description:
This study is a Phase III randomized placebo-controlled double-blind clinical trial of the immunogenicity and safety of 2 dose levels of a recombinant human parvovirus B-19 vaccine VAI-VP705 The vaccine is composed of viral capsids that incorporate 2 B-19 proteins VP-1 and VP-2 There will be 3 sites participating in this study Cincinnati Childrens Hospital Medical Center Baylor College of Medicine and the University of Maryland School of Medicine Eighty-nine parvovirus B-19 seronegative healthy adults 18-45 years old will be randomized to 1 of 4 groups 25 mcg VAI-VP705 with the adjuvant MF59 25 mcg with the adjuvant MF59 25 mcg without the adjuvant MF59 or placebo saline control Each participant will receive 3 separate vaccinations Months 0 1 and 6 and will continue in the study for up to approximately 14 months Study participants will be followed to evaluate safety and immune response The primary study objective is to evaluate the safety of VAI-VP705 administered with and without MF59 adjuvant in healthy parvovirus B-19 seronegative adults The secondary study objectives are to evaluate the immunogenicity of primary and booster immunizations of 25 mcg of VAI VP705 with and without MF59 and 25 mcg with MF59 compare the antibody response of vaccine administered with MF59 at each of 2 doses 25 and 25 mcg versus 25 mcg of vaccine administered without MF59 and evaluate the duration of the immune response 12 months after primary immunization The primary endpoint is the number and percentage of study participants who experience any vaccine-associated adverse events or serious adverse events The secondary endpoints include the percentage of study participants who develop neutralizing antibody responses against parvovirus B-19 28 days following the last dose of vaccine the percentage of study participants who maintain a neutralizing antibody titer at 12 months after primary immunization the geometric mean antibody titers as measured by enzyme-linked immunosorbent assay by treatment group at 28 days and at 12 months after primary immunization and the geometric mean neutralizing titers per treatment group at 28 days and at 12 months after primary immunization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None